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Thursday, 18 December 2014

Ova and out! "AG Villalón's parthenotes Opinion in IMC could provide stem cell research certainty (at least for now...)" was the title of a helpful note by Shohta Ueno (an Associate with Allen & Overy's IP Litigation team in London) on the first stage of the Court of Justice's ruling in Case C-364/13International Stem Cell Corporation v Comptroller General of Patents. This case, following a reference for a preliminary ruling from Henry Carr QC, sitting as a Deputy Judge in the Patents Court, England and Wales, seeks guidance on the following question:

Are unfertilised human ova whose division and further development have been stimulated by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells and are incapable of developing into human beings, included in the term "human embryos" in Article 6(2)(c) of Directive 98/44/EC on the legal protection of biotechnological inventions?

This morning the CJEU ruled that:

"... in order to be classified as a ‘human embryo’, a
non-fertilised human ovum must necessarily have the inherent capacity of developing into a
human being. Consequently, the mere fact that a parthenogenetically-activated human ovum
commences a process of development is not sufficient for it to be regarded as a ‘human
embryo’".

3 comments:

Anonymous
said...

Good, clear judgment which refrained from going down the route of the AG who suggeste ddealing with genetic manipulations a spart of th enotion. However, this judgment will be buried in the light of the other big judgments out today- obesity could be a disability and non-EU family members don’t need visa to enter UK.

Clearly a judgment very much limited to the specific facts. Brustle probably went to far in defining 'human embryo' and so this judgment is essentially cutting the definition back a little in the insistence that the ovum/parthenote has to have the ability to develop into a human being.

With no criticism meant of the judgment what these CJEU cases are not giving us are broad guidelines on what it is to be 'human' or an 'embryo'. Parthenotes only develop to 5 days, but suppose they were made to develop further and have functioning neuronal systems?

There are discussions happening out there about whether 'disabled' embryos are 'embryos', e.g. having a gene knocked out that prevents development beyond a certain point (see https://cbhd.org/content/ethical-embryonic-stem-cell-research). Parthenotes could be seen to be disabled embryos, which has implications for how they should be treated.

The decision was correct, but it avoided a comprehensive discussion of the issue, and I am unsure as to whether that was a lost opportunity.

For this particular Court made up of judges who now come from some hugely conservative MS notably the new MS (a pre-2004 bench would be very different) and with a reporting judge from the most conservative of them all on issues such as this one -this was a very generous judgment.And for a Grand Chamber judgment, there is very little to demonstrate that there was dissent which usually leads to the odd strange paragraph being inserted in there.In particular, the oddities in the AG's opinion were not taken over (e.g. MS can still prohibit, manipulation should be avoided).They also stuck to the question as asked to enable the national judge to resolve the dispute before them.

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